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Interobserver Variation in Applying a Radiographic Definition for Acute Respiratory Distress Syndrome (ARDS)

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ClinicalTrials.gov Identifier: NCT01704066
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : December 21, 2012
Sponsor:
Information provided by (Responsible Party):
Bin Du, Peking Union Medical College Hospital

Brief Summary:

The original American-European Consensus Conference (AECC) definition of Acute Respiratory Distress Syndrome (ARDS) required bilateral infiltrates consistent with pulmonary edema on frontal chest X-ray (CXR), but there is poor inter-observer reliability in interpreting CXR using this definition among intensivists and radiologists.

As a result, the newly published Berlin definition of ARDS specified that the CXR criterion should include bilateral opacities consistent with pulmonary edema not fully explained by effusions, lobar/lung collapse, or nodules/masses on CXR.

In order to improve inter-observer agreement, the panel have also developed a set of CXRs judged as consistent, inconsistent, or equivocal for the diagnosis of ARDS.

The objective of this study is to investigate the impact of this training set on inter-observer reliability in applying the radiographic definition for ARDS.


Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome Other: Training and education

Detailed Description:

The study is composed of 3 phases:

Phase 1: All participants will be required to independently interpret a set of 12 CXRs, as provided by the consensus panel. The possible radiographic interpretations include consistent, inconsistent, or equivocal for the diagnosis of ARDS.

Phase 2: Training materials adapted according to the recently published Berlin definition of ARDS, with its expanded rationale and interpretation of all 12 CXRs, will be sent to all participants.

Phase 3: The same set of 12 CXRs, in different order, will be sent to all participants for interpretation for the second time.


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Study Type : Observational
Actual Enrollment : 286 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Interobserver Variation in Applying a Radiographic Definition for ARDS: Impact of a Training Set of Berlin ARDS Definition
Study Start Date : October 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012





Primary Outcome Measures :
  1. inter-observer agreement in the interpretation of CXRs for the diagnosis of ARDS [ Time Frame: immediately after reading the CXRs ]

Secondary Outcome Measures :
  1. Impact of the training set on the inter-observer agreement on the interpretation of CXRs [ Time Frame: difference of inter-observer agreement before and after the training course ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Intensivists working in the participating ICUs
Criteria

Inclusion Criteria:

  • intensivists working in the participating ICUs

Exclusion Criteria:

  • those who could not participate both questionnaire surveys
  • those who have read the reference with the training set of CXRs before the study
  • those who have already known the objective of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704066


Locations
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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Society of Critical Care Medicine, China
Investigators
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Principal Investigator: Bin Du, MD Peking Union Medical College Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bin Du, Professor and Director, Medical ICU, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01704066     History of Changes
Other Study ID Numbers: CCCCTG-2012-ARDS-01
2012BAI11B05 ( Other Grant/Funding Number: National Key Technology R&D Program Project 2012BAI11B05 )
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: December 2012
Keywords provided by Bin Du, Peking Union Medical College Hospital:
ARDS
Chest radiograph
Berlin Definition
Inter-observer agreement
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury